MiMedx Provides Additional Information and Context to Wall Street Journal Article

MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today provided additional background and context to certain points, including third party statements, in an article published by The Wall Street Journal (‘WSJ’) on August 14, 2018:

MiMedx products are manufactured according to current Good Tissue Practices (cGTP) standards, pursuant to the Food and Drug Administration (‘FDA’) regulations specified in 21 CFR 1271, which are the requirements and guidelines the Company must follow. MiMedx is also in compliance with the American Association of Tissue Banks’ 14th standard, of which the Company is a fully accredited member in good standing.

In addition, certain MiMedx products are marketed as cellular and tissue based products (‘HCT/Ps’) under Section 361 of the Public Health Service Act until either a biologics license application (‘BLA’) by the Company is approved or the FDA’s enforcement discretion under the November 2017 guidance document¹ ends. Since the 2016 inspection report from the FDA referenced by the WSJ, MiMedx has continued its transition to cGMP compliance for certain products as it conducts clinical trials to seek approval for certain indications under a BLA filing for its micronized dehydrated Amnion/Chorion Membrane (‘dHACM’) injection (AmnioFix® Injectable).

In terms of the clinical evidence supporting the Company’s products, MiMedx continues to build its compendium of clinical studies, including numerous randomized controlled studies, to support the use of EpiFix®. In addition, the Company has three ongoing investigational new drug programs with the FDA covering clinical studies intended to support an eventual BLA for micronized dHACM injection. As an example, interim results from a Phase 2B multicenter, randomized controlled trial evaluating the use of micronized dHACM injection as a treatment for Plantar Fasciitis were recently published in Foot and Ankle International. The interim results reflected statistically significant improvement in pain and foot function compared to the placebo control group. MiMedx also began enrolling patients into its Phase 3 Plantar Fasciitis trial in January 2018.

Selling micronized amniotic tissue-based products is a broad industry matter now covered by a finalized guidance document¹ from the FDA on homologous use and minimal manipulation of HCT/Ps. The guidance stated that all micronized amniotic products would require a biologics license to be lawfully marketed in the United States, and that FDA would use its enforcement discretion to provide a 36-month transition period. MiMedx is committed to the transition process as described in the November 2017 guidance. In the meantime, and until the end of the transition period, MiMedx continues to sell its micronized allograft products as HCT/Ps in the United States.

MiMedx continues to make progress on its market expansion objectives and clinical trial programs while continuing to maintain positive operating cash flow with no outstanding long-term debt. The Board and management team remain focused on positioning MiMedx to capitalize on the full array of opportunities presented by the Company’s processing capabilities, clinical science, customer relationships and scale.

As previously disclosed, the MiMedx Audit Committee is conducting an independent internal investigation into current and prior-period matters concerning sales and distribution practices and other matters. The Audit Committee is working diligently with its advisors to complete the investigation, and the Company is also working to prepare its financial statements for audit and regain compliance with Securities and Exchange Commission reporting obligations as soon as practicable.

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